P03 SSJ BEDAC Brain Bank Signedp.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 09 Page 1 of 3 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 523 20 4 1866 0049 / 36C241 20 AP 1617

Contracting Activity: Department of Veterans Affairs, VISN 01, VA Boston Healthcare System Mental Health Initiative Office, Jamaica Plain Campus, 150 S. Hunting Avenue, Boston, MA 02130.

Nature and/or Description of the Action Being Processed: The VA Boston HCS has a requirement for support of it’s Brain Bank Repository which consists of database maintainance of REDCap systems for collecting, entering, tracking, reviewing, cleaning, and reporting project data; web based training and booster training; implementation of SAS based data management and quality control procedures; participant level data cleaning; analytic dataset creation including derived variables and appropriate documentation; development and maint nance of reports; statistical analyses.

The resulting contract will be firm fixed price for a base plus four option years. Base Year cost = $105,212.00; Total Award Value = $568,865.00

Description of Supplies/Services Required to Meet the Agency’s Needs: The Biostatistics and Epidemiology Data nalytics Center (BEDAC) personnel will coordinate all data collection and management activities for the project and provide supervision for all data management staff. Under the direction of the study investigators and project biostatistician, BEDAC personnel will advise on and assist with data collection system design and development; oversee data collection form development; oversee design and construction of electronic data systems; oversee development of manuals for all data systems; assist in the development and implementation of web based randomization where applicable; develop protocols for secure data transfer of any reasonable external data elements; oversee development of data management plans; act as liaison among statisticians, data management personnel, field personnel, and other investigators; participate in program meetings and individual project meetings; oversee development of SAS programming for data cleaning procedures, dataset creation, reporting, analysis and data sharing; participate in VA training as appropriate.

Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302 1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302 2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302 3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302 4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302 5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302 6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302 7;

OFOC SOP Revision 09 Page 2 of 3 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The VA Brain Bank has been collaborating with BU Data Center for the last five years. The work was begun through Intergovernmental Personnel Act (IPA) assignments. Boston University is no longer in agreement to continue an IPA so a one year contract to complete the BEDAC data compilation is needed. To ensure there is continuity in data collection and development it is imperative that services are continued through the VA’s partner in this ongoing study, Boston University. They are the only ones with access to the data systems that they created.

This is a continuing joint research effort between the Department of Veterans Affairs PTSD Research Brain Bank and the Boston University Biostatistics and Epidemiology Data Analytics Center. The continuation of the data collection and management is imperative for the program’s success and services are a logical follow on to the existing project that was previously funded via Intergovernmental Personnel Act assignments. Award to any source other than the Boston University BEDAC Department would jeopardize the success of the research program and/or create unacceptable delays.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Because this is an ongoing and joint research study, it is not possible to farm out the data management and analysis to another contractor not involved as a partner in the study.

In the future, if the joint research relationship is no longer continued, the management of the data (as opposed to its analysis) may be a service which could be provided by other vendors following consultation with the Service and provision of a new Performance Work Statement.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Pricing for research studies with affiliated universities is dictated by the Department of Health and Human Services in a College and University Rate Agreement. The agreement is published bi annually by the DHHS to establish wage rates for professional services provided by VA affiliated Universities. The pricing of this contract will be in accordance with those identified in the DHHS rate agreement.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

OFOC SOP Revision 09 Page 3 of 3 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona

Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Latease Guilderson Date Health Science Specialist VA Boston HCS

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Anna Norcross Date Contracting Officer RPO East Network Contracting Office 01

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Lorrie Baines Date Branch Chief, Services Team RPO East, Network Contracting Office 01

LATEASE

GUILDERSON 548157

Digitally signed by LATEASE

GUILDERSON 548157

Date: 2020.05.28 13:30:15 -04'00'

Lorrie A. Baines 154610

Digitally signed by Lorrie A.

Baines 154610 Date: 2020.05.28 15:55:33 -04'00'

Anna D. Norcross 678489 Digitally signed by Anna D. Norcross 678489 Date: 2020.06.01 14:27:07 -04'00'

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: In the future, if the joint research relationship is no longer continued, the management of the data (as opposed to its analysis) may be a service which could be provided by other vendors following consultation with the Service and provision of a new Performance Work Statement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A